Practice Leadership

FDA Regulatory

Our highly experienced team guides life sciences clients through every aspect of the complex and evolving FDA regulatory landscape. With extensive understanding of the development and life cycle management of pharmaceutical products and medical devices, our lawyers–including former general counsel for Novo Nordisk, Forest Laboratories, and Robert Wood Johnson University Hospital Rahway, and in-house counsel for Savient Pharmaceuticals, Reliant Pharmaceuticals, Pfizer, and the FDA–understand the risks and rewards facing our clients in this sector.

The team works closely with our extensive, multidisciplinary Life Sciences Practice Group to advise and represent companies of all sizes, from startups to global leaders. We provide guidance on FDA regulatory issues related to product development and commercialization, post-approval promotion and compliance, intellectual property, government enforcement actions, and mergers and acquisitions.

We also are frequently tapped to share our perspective on the regulatory challenges shaping the global health care industry, and to speak at industry conferences, congressional briefings, and FDA public hearings. Companies turn to us for practical counsel in regard to related government agencies, including the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), and the Consumer Product Safety Commission (CPSC).

PRESS MENTIONS

James C. Shehan is quoted in an article discussing high drug prices and Congressional activity aimed at driving down rising costs. In The American Journal of Managed Care, his interview with The Center for Biosimilars is referenced, with Shehan commenting that the U.S. Congress has been “all talk and no action” for the last decade. States, however, Shehan notes, have taken concrete action on drug pricing, with almost every state having considered some kind of proposal and a number of laws enacted.

James C. Shehan is quoted in Law360 in an article discussing the Administration’s proposed regulation forcing disclosure of drug prices in TV ads. Shehan notes that the proposal pushes the limits of existing legal authority.

Pink Sheet quotes James C. Shehan in an article reporting pharmaceutical company Sanofi’s settlement with the U.S. Securities and Exchange Commission for violating the Foreign Corrupt Practices Act (FCPA). The article notes that this settlement follows a relatively quiet period for FCPA settlements. Shehan attributes the lack of FCPA enforcement activity to the fact that “there are fewer easy cases out there for prosecutors to go after,” that there can be a long period between the alleged violation and resolution of the case, and that companies have generally become more compliant with the law. (subscription required to access article)

Law360 interviews with James C. Shehan on a broad range of issues, including: critical skills for being a successful FDA lawyer, a move to streamline the FDA’s approval process, patent litigation involving biosimilars, FDA updates to off-label promotion guidance, a push in favor or competition and generics, and understanding why the FDA has reduced the number of warning and untitled letters for promotional issues. (subscription required to access article)

Law360 quotes James C. Shehan in an article discussing the likelihood of an increase in litigation against U.S. Food & Drug Administration (FDA) policies should the Hon. Brett Kavanaugh of the U.S. Court of the Appeals for the District of Columbia Circuit be confirmed to the U.S. Supreme Court. Judge Kavanaugh has criticized the Supreme Court’s Chevron doctrine, which mandates judicial deference to reasonable administrative agency interpretations of ambiguous federal laws, as enabling agencies to “stretch the meaning of statutes.” Shehan predicts that a shift by the Court on Chevron will spark more lawsuits against the FDA. He notes that while Chevron may still inspire judicial deference in cases involving complex scientific matters, any lessening of deference more generally would diminish the FDA’s authority. (subscription required to access article)

Modern Healthcare quotes James C. Shehanin an article profiling U.S. Food and Drug Administration commissioner Dr. Scott Gottlieb’s positive performance to date. Shehan states that Gottlieb is “the most prominent FDA commissioner in terms of getting out in front of the public” and that he is garnering approval from both the public and the pharmaceutical industry.

Modern Healthcare quotes James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, on how the FDA’s new Medical Device Safety Action Plan will fill gaps in device regulation and may portend further FDA action in other areas.

James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, is quoted in Modern Healthcare regarding the security of medical devices pertaining to health systems, noting the lack of absolute security in the electronic world.